Actively Recruiting
Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE
Led by Region Örebro County · Updated on 2026-04-07
90
Participants Needed
3
Research Sites
188 weeks
Total Duration
On this page
Sponsors
R
Region Örebro County
Lead Sponsor
T
The Swedish Heart and Lung Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this randomized, double-blind, placebo-controlled clinical trial is to investigate the immunological effects of influenza vaccination outside of the influenza season on arterial inflammation in patients with a recent acute myocardial infarction (AMI). The primary objective is to compare the effects of influenza vaccination to those of a placebo in reducing post-myocardial infarction coronary inflammation as measured by coronary computed tomography angiography (CCTA). The main questions it aims to answer are: Does influenza vaccination reduce arterial inflammation as measured by CCTA at week 8 after percutaneous coronary intervention (PCI) in comparison to baseline? Does influenza vaccination modulate systemic inflammation as measured by blood biomarkers and in-vitro challenge tests at week 8 after PCI in comparison to baseline? Researchers will compare the effects of influenza vaccination with those of a placebo.
CONDITIONS
Official Title
Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a diagnosis of non-ST-segment elevation myocardial infarction
- A finalized coronary PCI
- Male or non-fertile female subjects 18 years or older (including postmenopausal women and women with medical conditions preventing pregnancy)
- Written informed consent
- Ability to schedule a coronary CT angiography (CCTA) within 7 days after PCI
You will not qualify if you...
- Influenza vaccination received within the last 6 months
- Planned vaccination within 8 weeks, including COVID-19 booster doses
- Severe allergy to eggs or previous allergic reaction to influenza vaccine
- Planned cardiac surgery or staged PCI within 8 weeks
- Coronary stent involving the proximal right coronary artery
- Suspected febrile illness or acute infection
- Hypersensitivity to vaccine components such as ovalbumin, neomycin, formaldehyde, or octoxinol
- Endogenic or iatrogenic immunosuppression reducing immunization response
- Inability to provide informed consent
- Previous participation in this trial
- Non-cardiovascular conditions with life expectancy less than 1 year
- Contraindications to coronary CT angiography (e.g., inability to lie flat, contrast allergy, severe kidney impairment)
- Atrial fibrillation
- Uncontrolled chronic inflammatory disease
- Inability to comply with study protocol requirements
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Aarhus University Hospital, Department of Cardiology
Aarhus, Denmark, DK-8200
Actively Recruiting
2
Örebro University Hospital
Örebro, Sweden, 70185
Actively Recruiting
3
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
Research Team
S
Sara Cajander, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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